MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721001S

Device Problem Torn Material (3024)

Patient Problem Not Applicable (3189)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2018, the surgery for adult scoliosis was performed by using the expedium verse system.The fixed area was t10 ¿ s2.The sai screw was used for only s2.After all the screws were inserted, the unitized set screws were temporarily placed by using the single inserter (2797.02.000).(the collection key was used for l4 and l5).Thereafter, in order to make final tightening from the s2 screw, when the surgeon tried to make final tightening by using a combination of the torque limiting handle (2997.04.320) and versex25 set screw driver (2997.04.230), the surgeon told that the tip of the driver did not fit the set screw.After pressing the torque driver harder, the surgeon told that the tip of the driver did fit the set screw.Although the surgeon tried to make final tightening, the tip of the set screw driver was broken, and final tightening could not be done.Even though another set screw was used, the tip of the screw driver had been already deformed.Thus, the tip of the second screw driver did not fit the set screw well either.Afterwards, another (third) set screw driver was used from a backup verse b tool set.The tip of the third screw driver did fit the set screw well, and final tightening was completed safely.The collection key and the unitized set screw became cross-threaded and broken as well.The surgery was completed with no delay, and there was no adverse consequence to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination of the 5.5 exp verse unitized set scr reveals signs of operative use as evidenced by superficial markings, with its lead thread peeled off which consists of approximately 1/4th turn of thread material, which is attached to the screw.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the 55.5 exp verse unitized set scr cannot be determined.This damage may have potentially occurred due to cross-threading a set screw upon insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE UNITIZED SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7313157
• MDR Text Key: 101850802
• Report Number: 1526439-2018-50200
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466149
• UDI-Public: 10705034466149
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721001S
• Device Lot Number: UL1232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 03/08/2018; 04/16/2018
• Supplement Dates FDA Received: 04/04/2018; 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR